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| Tracking Information | |
|---|---|
| First Received Date ICMJE | June 11, 2008 |
| Last Updated Date | June 12, 2008 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00696930 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors |
| Official Title ICMJE | A Phase II Open-Label Multi-Center Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors |
| Brief Summary | Subjects will be screened to determine OctreoScan® uptake. And upon meeting the eligibility criteria, 90 subjects will complete a symptom assessment scale at baseline and throughout the study at specific time points. Actual treatment will consist of three six-week cycles of a fixed total dose of 13.3 GBq (360 mCi) of 90Y-SMT487. The total dose will be divided into three equal doses and administered as a single activity of 4.4 GBq (120 mCi) of 90Y-SMT487 once every six weeks for three cycles. An amino acid infusion will be administered along with each dose. Long-term follow up will occur at 6 and 12 months after Day 1/ Cycle 1. Survival will be assessed every six months. |
| Detailed Description | |
| Study Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Safety/Efficacy Study |
| Condition ICMJE | Malignant Carcinoid Tumor |
| Intervention ICMJE | Drug: 90Y-SMT487 |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | |
| Administrative Information | |
| NCT ID ICMJE | NCT00696930 |
| Responsible Party | Molecular Insight Pharmaceuticals, Inc. |
| Study ID Numbers ICMJE | CSMT 487A 2202 |
| Study Sponsor ICMJE | Molecular Insight Pharmaceuticals, Inc. |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Molecular Insight Pharmaceuticals, Inc. |
| Verification Date | June 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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